Esophageal squamous cell carcinoma
Conditions
Interventions
Adebrelimab group:Neoadjuvant Therapy with Adebrelimab
Sponsors
Anhui Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old, male or female; 2.Histopathologically confirmed esophageal squamous cell carcinoma via biopsy, with resectable esophageal cancer before enrollment; 3.Thoracic esophageal cancer confirmed by CT/MRI imaging, with clinical stage cT1b-cT2 N+ M0 or cT3-cT4 any N M0 (per the 8th edition of AJCC staging system); 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1 (see Appendix 1 for ECOG scoring criteria); 5.Expected survival >= 3 months; 6.No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.; 7.No severe hematopoietic, cardiac, pulmonary, hepatic, renal dysfunction or immunodeficiency; 8. Adequate function of major organs (No blood products, cell growth factors, leukocyte-elevating agents, platelet-boosting drugs or anti-anemia medications are permitted within 14 days prior to the first administration of study drug): Absolute neutrophil count (ANC) >= 1.5×10^9/L; Hemoglobin (Hb) >= 9 g/dL; Platelet count (PLT) >= 100×10^9/L; Total bilirubin <= 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) <= 2.5 × ULN; Serum creatinine <= 1.5 × ULN. 9.The subject signs the informed consent form and participates in this study voluntarily.
Exclusion criteria
Exclusion criteria: 1. Esophageal perforation or hematemesis; 2.Presence of any active autoimmune disease or medical history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [subjects receiving effective hormone replacement therapy are eligible]), with use of immunosuppressive agents within 28 days prior to enrollment; 3. Known hypersensitivity to macromolecular protein preparations, or to adebrelimab or any excipients contained in its formulation; 4. Uncontrolled cardiac clinical manifestations or diseases, including: (1) heart failure of NYHA Class II or above; (2) unstable angina pectoris; (3) myocardial infarction within the past 12 months; (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 5.Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA >= 10^4 copies/mL) or active hepatitis C (positive anti-HCV antibody with HCV-RNA above the lower limit of quantification of the assay), or active tuberculosis; 6. Active infection, or unexplained fever > 38.5 °C within 2 weeks before randomization (subjects with tumor-related fever as judged by the investigator may be enrolled); 7.Fertile male or female subjects unwilling to use effective contraception throughout the trial; female subjects who are pregnant or breastfeeding; 8.Other conditions judged by the investigator to force premature study discontinuation, such as other severe illnesses (including psychiatric disorders) requiring concurrent treatment, family or social factors, or any conditions that may compromise subject safety or trial data collection; 9.Outpatients or inpatients with initial or follow-up hospital visits whom the investigator deems inappropriate for trial participation for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival;Overall Survival;Objective Response Rate;Safety;Major Pathological Response;Resection rate; | — |
Countries
China
Contacts
Public ContactCheng Cao
Anhui Public Health Clinical Center
Outcome results
None listed